University of Southern Denmark
Thank you to Ewa Roos and all the staff at Southern Denmark University for hosting me and sharing their current research projects. One exciting project we discussed is “The Dream Trial”, being conducted by Associate Professor Soren Skou together with Associate Professor Jonas Thorlund.
I met with Associate Professor Jonas Thorlund, from the Department of Sports Science and Clinical Biomechanics, Research Unit for Musculoskeletal Function and Physiotherapy to discuss “The Dream Trial”. The Dream Trial is is a random controlled trial comparing meniscal surgery with a combined exercise and education program, for young people with confirmed meniscal injury. Their hypothesis is that patients randomised to surgery will improve significantly more in pain, function and quality of life after 12 months than those randomised to exercise and patient education.
I have attached the abstract for the study protocol- the full article can be viewed on Open Access.
Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults
Søren Thorgaard Skou,1,2 Martin Lind,3 Per Hölmich,4 Hans Peter Jensen,5 Carsten Jensen,6,7 Muhammad Afzal,8 Uffe Jørgensen,9 Jonas Bloch Thorlund1
Abstract
Introduction
Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears.
Methods and analysis
This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18–40 years with a clinical history and symptoms consistent witha meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon will be randomly allocated to one of two groups (1:1 ratio). Participants randomised to surgery will undergo either arthroscopic partial meniscectomy or meniscal repair followed by standard postsurgical care, while participants allocated to exercise and education will undergo a 12-week individualised, supervised neuromuscular and strengthening exercise programme and patient education. The primary outcome will be differencein change from baseline to 12 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, function in sports and recreation and quality of life (Knee Injury and Osteoarthritis Outcome Score (KOOS4)) supported by the individual subscale scores allowing clinical interpretation. Alongside, the RCT an observational cohort will follow patients aged 18–40 years with clinical suspicion of a meniscal tear, but not fully eligible or declining to participate in the trial.
Ethics and dissemination
Results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Regional Committees on Health Research Ethics for Southern Denmark. Registration details ClinicalTrials.gov (NCT02995551).
Starr and Dream Trials
The Starr Trial is a similar project to the Dream Trial. It is being conducted at Erasmus Medical Centre, Rotterdam by Dr Sussan Eijgenraam. The Starr Trial is an RCT looking at
· Traumatic meniscal tears (confirmed on MRI) in 152 people,
· Age group 18-45 yrs, comparing partial meniscectomy versus 12 sessions of a physical rehabilitation program.
Outcomes of the treatment groups will be collected at 2 years including pain / function as measured by the IKDC. KOOS, WOMET, Lysholm, NRS, EQ-5D scores and cost effectiveness. T2 mapping MRI’s comparing cartilage quality across the groups and histology studies in the surgical group are also being reported. Preliminary data collected has shown that some traumatic tears may have some pre existing degenerative changes in the cartilage.
The Clinical Translator:
We now have data to show arthroscopic partial meniscectomy was not superior to sham surgery in people with a degenerative medial meniscal tear with no OA (Fidelity Study, 2015 ). Katz et al (2013) also showed partial meniscectomy and physical therapy was not superior to physical therapy alone for people with a degenerative meniscus tear and OA. To date there are no studies on young people with meniscal tears comparing non-operative and operative management.
The Dream and the Starr study are important research projects to inform us of treatment options for younger people with meniscal tears / pathology. As a clinician I think it is important to read the inclusion and exclusion criteria to understand the applicability of results to an individual patient. The inclusion criteria for both studies (* see full text) are broad and includes many young people I would see with a meniscal injury. The exclusion of the Dream study: previous knee surgery / major knee ligament ruptures/ acute locked knee/ displaced bucket handle tear/ fractures in that lower limb in past 6/12. The Starr study exclusion criteria are similar but also excludes repairable meniscal tears as confirmed on MRI and other co-morbidities. The exercise program of the Dream study was tested in a pilot trial and consisted of initial range of movement exercises and swelling control, followed by strength endurance and neuromuscular training gradually progressed to hypertrophy training. An education program accompanied the training program.
This is intended as an aid to the clinician to translate research findings into clinical practice but is my own opinion based on the available current research evidence and my clinical expertise and experience. Clinicians should consider if this advice is appropriate for them and use their own reasoning processes considering the individual patient in question
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